Drug Abuse
Glaxo failed to warn of diabetes drug risk
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The widow and son of a Texas man who was taking a GlaxoSmithKline Plc diabetes drug at the time of his fatal heart attack claims the drugmaker failed to warn about the drug’s risks, according to a lawsuit.
The claim involves rosiglitazone, which is sold under the brand names Avandia and Advandamet. Investors have been bracing for a flood of litigation against Glaxo after a widely publicized medical report suggested Avandia increases the risk of heart attack.
Diabetes group urges patient caution on Avandia
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The latest studies on Avandia, GlaxoSmithKline’s blockbuster diabetes drug, have raised enough questions about the drug’s safety to worry the American Diabetes Association.
Several studies now suggest the drug, which lowers blood sugar levels, may raise the risk of heart attack. Glaxo researchers rushed out an interim analysis of an ongoing study on Tuesday the company said showed no increased risk, but independent experts disagreed.
Glaxo’s Avandia raises heart-death risk: study
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Avandia, GlaxoSmithKline Plc’s widely used drug for treating type 2 diabetes, increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent, U.S. researchers said on Monday.
The news about Avandia, also known as rosiglitazone, triggered a freefall in GSK’s shares, which closed off more than 5 percent on the London Stock Exchange. The stock slide continued on the New York Stock Exchange, falling $3.67 per share, or more than 6 percent.
Heart experts say Merck arthritis drug too risky
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Two prominent U.S. heart experts said studies of Merck & Co. Inc. arthritis drug Arcoxia revealed risks that should prevent its approval in the United States and that the drug posed unacceptable dangers in the 63 countries where it is already sold.
The concerns were expressed on Thursday by Steven Nissen, head of cardiology at the Cleveland Clinic, and Dr. Curt Furberg, a professor of public health at Wake Forest University who is a member of the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration.
Overuse of skin numbing creams can cause death: FDA
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People who use large amounts of skin-numbing creams and lotions, often in conjunction with cosmetic procedures, are at risk of irregular heartbeats, seizures and even death, U.S. health officials warned on Tuesday.
The Food and Drug Administration, citing two deaths, said such topical anesthetics can be applied in amounts so large that a lethal dose of the chemicals can enter the bloodstream.
Heart drug may improve preterm labor outcomes
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Treatment with transdermal nitroglycerin can prolong pregnancy in women who go into labor prematurely and its use seems to reduce illness in the newborn, a study shows.
While a number of drugs called tocolytics that block uterine contractions can prolong pregnancy, “none have been shown to improve neonatal outcomes,” lead author Dr. Graeme N. Smith, from the Kingston General Hospital in Canada, told Reuters Health.
Cancer risk from arthritis drugs overstated-study
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Two biotech drugs used to treat rheumatoid arthritis—Abbott Laboratories Inc.‘s Humira and Johnson & Johnson’s Remicade—may raise the risk of cancer and infections but not as much as was feared, researchers said on Tuesday.
A series of letters published in the Journal of the American Medical Association show that several teams have taken a fresh look at the safety of the two drugs and find that they may double the risk of cancer and infections.
Most of the researchers, and the U.S. Food and Drug Administration, agree that patients need to know about the risks but say the benefits mean the drugs should stay on the market.
Prozac plus Ecstasy a toxic combo
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The combination of the antidepressant drug Prozac and the illegal “club drug” Ecstasy increases the risk of acute toxic effects of Ecstasy, and may explain the increasing number of Ecstasy-related deaths, according to research presented at the annual meeting of the American College of Clinical Pharmacology, held here this week.
In presenting the research, Dr. Vijay V. Upreti, of the University of Maryland, Baltimore, said an increasing number of Ecstasy abusers are combining the drug with Prozac in an effort to counteract the depression that occurs after the drug’s high wears off. Ecstasy, also known as MDMA, helps the body relax, reduces inhibitions and increases energy and brings feelings of euphoria.
Upreti and colleagues measured brain and blood levels of MDMA in mice after a 5 mg/kg-dose of MDMA. Levels were also measured after pretreatment with Prozac followed by 10 mg/kg MDMA.
Vioxx risks confirmed by new studies
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The use of Vioxx (rofecoxib), the anti-inflammatory drug at the center of many high-profile lawsuits, does, in fact, increase the risk of heart attacks and strokes and may also adversely affect kidney function, according to the results of two studies released early by the Journal of the American Medical Association.
Both reports suggest that only Vioxx, not other COX-2 inhibitors, markedly raises the risk of these events.
Dr. Jingjing Zhang, from Harvard Medical School in Boston, and colleagues conducted an analysis of data from clinical trials to compare the kidney and heart rhythm risks associated with COX-2 inhibitors, including Vioxx, Celebrex (celecoxib), and others. A search of medical databases yielded 114 relevant trials with 116,094 participants.
German insurers review Plavix after negative study
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German health insurers, under pressure to cut costs amid reforms, are considering whether to restrict prescription guidelines for Sanofi-Aventis’s blood thinner Plavix in a move that could harm the drug’s sales.
A spokeswoman for the Joint Committee (B-GA), the self-regulating body of German health insurers, said on Tuesday it was reviewing a report it had commissioned from an independent research institute which questions the benefits of Plavix for certain patients.
The German Institute for Quality and Efficiency in Healthcare (IQWiG) said clopidogrel, marketed by Sanofi-Aventis and Bristol-Myers Squibb as Plavix or Iscover, offered no benefits over aspirin when used alone as a preventative treatment for conditions resulting from arterial diseases.
Merck moves forward with Vioxx successor
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Drugmaker Merck & Co. on Wednesday gave preliminary results of a study of its investigational painkiller Arcoxia, the planned successor to Vioxx, which was pulled off the market in 2004 after being linked to stroke and heart attack.
Merck said the study, comparing Arcoxia with the anti-inflammatory drug diclofenac, found the “relative risk” of certain cardiovascular events was similar.
The incidence of patients withdrawing from the study due to side effects related to high blood pressure, edema and congestive heart failure was significantly higher for Arcoxia than for diclofenac, it said.
Merck loses Vioxx case, told to pay $51 million
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A federal jury on Thursday found that Merck & Co. Inc. was negligent and knowingly made misrepresentations about its withdrawn pain medicine Vioxx, and awarded $51 million to the plaintiff.
The New Orleans jury, in the second federal trial involving a Vioxx product-liability lawsuit, found that Merck had knowingly misrepresented or failed to disclose a material fact to the plaintiff’s physicians and that doctors in the case and the plaintiff himself were not at fault.
The plaintiff, Gerald Barnett, a 62-year-old retired FBI agent who had a heart attack in 2002 after taking Vioxx for 31 months, was awarded $50 million in compensatory damages and $1 million in punitive damages.
Dodgy Chinese antibiotic kills at least 7
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According to the Ministry of Health in China at least 7 deaths have now been linked to the injectable antibiotic clindamycin phosphate glucose.
The ministry has apparently demanded that all provincial health departments report cases of adverse reactions to the antibiotic an a daily basis.
The government banned the use of the drug last week, following the death of a 6-year-old girl and scores of others suffering adverse reactions.
US tells 3 companies to stop making unapproved drugs
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U.S. authorities said on Thursday they told three companies to stop mass-producing and distributing unapproved medicines to treat asthma, bronchitis and other breathing disorders.
The Food and Drug Administration said the companies sold thousands of doses of inhaled drugs nationwide. The companies argued they were working under a practice known as “compounding” in which pharmacists customize formulations for specific patients, the FDA said.
The FDA allows compounding if a doctor prescribes something that meets a medical need and is unavailable in an approved product. A pharmacist, for example, could crush a tablet and mix it into a liquid for someone with trouble swallowing pills, or provide a version without a preservative that could cause an allergic reaction.
Malaysia’s religious scholars ban Botox treatments
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Malaysia’s religious scholars have ordered devout Muslims not to use Botox injections to smooth away wrinkles because they contain prohibited substances, such as those from pigs, a newspaper said on Friday.
But the injections will be allowed to help alleviate medical conditions such as cerebral palsy, the New Straits Times said, adding that while the fatwa did not have the force of law, those who ignored it were committing a sin.
Even in medical treatment, the injections must only be provided by a specialist in dire cases, said Shukor Husin, chairman of the National Fatwa Council.
